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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ROD, FIXATION, INTRAMEDULLARY

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SYNTHES USA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for unknown helical blade/unknown lot number. Patient had original surgery sometime in the (b)(6) 2017. Device is not expected to be returned for manufacturer review/investigation. (b)(4). Patient fell and presented to the hospital with pain. The following day, surgeon removed all implants (intact) due to the fracture extending below the nail and revised the patient to a longer tfna nail construct. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was report that the patient had original surgery sometime in the (b)(6) 2017, at a different unknown hospital where a (tfna) trochanteric fixation nail advanced construct was implanted. Patient was implanted with one (1) short tfna nail, one (1) helical blade and one (1) distal locking screw. Post-operative, on (b)(6) 2017, patient fell and was taken at the hospital. Patient presented with pain. On (b)(6) 2017, surgeon removed all implants (intact) due to the fracture extending below the nail and revised the patient to a longer tfna nail construct. It was reported that no fragments were generated during implant removal. All implants have been retained by the hospital. Revision surgery was completed successfully with no time delay. Patient is reported in stable condition. Sales consultant has no more information to report on this event. This report involves 3 devices. This report is 3 of 3 for (b)(4).
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6893956
MDR Text Key87352155
Report Number2520274-2017-12338
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/26/2017 Patient Sequence Number: 1
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